Anlotinib hydrochloride was approved for marketing under the trade name FuKeWei® by the NMPA on May 9, 2018 for the third-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The fast time to market of anlotinib hydrochloride was made possible by the Chinese government's support for accelerated evaluation and approval of innovative drugs.
According to researcher, as of September 2021, anlotinib has been approved in China for four indications: (1) advanced NSCLC (2) soft tissue sarcomas (3) small cell lung cancer (4) advanced or metastatic medullary thyroid cancer.
In 2020, there were 4.57 million new cancer cases in China, 820,000 of which were lung cancer cases. Lung cancer is mainly divided into small cell lung cancer and non-small cell lung cancer (NSCLC), and the latter accounts for about 80-85% among all patients with lung cancer, most of which are diagnosed as locally advanced or metastatic disease. Soft tissue sarcomas are a group of rare cancers with low incidence that account for only 1% of all malignancies. But it is characterized by high evolution possibility, poor prognosis, high insidiousness, and inconspicuous early symptoms, making it extremely difficult to treat clinically. According to researcher’s estimation, there were about 220,000 new cases of thyroid cancer in China in 2020, among which medullary thyroid carcinoma (MTC) accounts for about 2%-4%. MTC is more likely to have malignant evolution and distant metastasis, and the treatment may not impose good effects for patients with advanced stage.
According to researcher, the sales value of anlotinib in the Chinese market was approximately CNY922 million (USD142 million) in 2020, with a CAGR of 444% from 2018 to 2020. Generic drugs of anlotinib from other Chinese pharmaceutical companies are expected to be on the market around 2024, so China’s anlotinib market will remain fully occupied by Chia Tai Tianqing Pharmaceutical's product till 2025.
researcher expects that China’s anlotinib market will continue to grow from 2021 to 2025 as new cancer cases are expected to increase in China due to environmental pollution and lifestyle changes.
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